Registration Dossier
Registration Dossier
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EC number: 271-770-5 | CAS number: 68607-88-5 Substance obtained by acidic, alkaline, or enzymatic hydrolysis of soya composed primarily of amino acids, peptides, and proteins. It may contain impurities consisting chiefly of carbohydrates and lipids along with smaller quantities of miscellaneous organic substances of biological origin.
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- October 2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- Principles of method if other than guideline:
- N/A
- GLP compliance:
- yes
Test material
- Reference substance name:
- Protein hydrolyzates, soya
- EC Number:
- 271-770-5
- EC Name:
- Protein hydrolyzates, soya
- Cas Number:
- 68607-88-5
- IUPAC Name:
- Enzymatic hydrolysis products of Glycine soya
- Test material form:
- liquid
- Details on test material:
- Amber liquid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Three male albinos rabbits of New Zealand strain, numbered A4933, A4934, A4935, originated from the elevage de Gérome (40260 Linxe) were kept during 6-day acclimatation period. During the test, the animals were weight between 2.17 kg and 2.37 kg.
Animals were kept in individual boxes, the environnement conditions were:
- temperature : 21 to 22°C
- relative humidity : 46% to 53%
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- A volume of 0.1 ml of the pure product was instilled into one eye of each rabbit, the other eye untrated serving as control.
- Duration of treatment / exposure:
- Ocular examinations were performed on both right and left eyes 1 hour after instillation and 24, 48 and 72 hours
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 3 rabbits
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- other: Not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- other: Not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- ca. 0
- Max. score:
- 0
- Reversibility:
- other: Not applicable
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Ocular irritation indices:
1 hour: average : 4
24 hours: average : 0
48 hours: average : 0
72 hours: average : 0
Maximum ocular irritation index : MAX. O.I : 4 - Other effects:
- It was only recorded a slight redness and a lachrymation in the 3 animal on examination time 1 hour
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The results obtained in the experimental conditions, enable to conclude that the test product is slightly irritant for eye (max O.I. = 4) according to the classification established in the Journal Officiel de la République Française date July 10th, 1992 and must not be classified according to the criteria of classification, packaging and labelling of dangerous substances in compliance with the E.E.C Directive 67/548 and 99/ 45
- Executive summary:
An in vivo study was performed on New Zealand albino rabbit according to OECD guidelines number 405 of February 24, 1987 and EEC guidelines 67/548.
The test item was intilled in the eye of 3 rabbits, by a 0.1 ml dosage. The eye was not rinsed.
The results obtained in the experimental conditions, enable to conclude that the test product is slightly irritant for eye (max O.I. = 4) according to the classification established in the Journal Officiel de la République Française date July 10th, 1992 and must not be classified according to the criteria of classification, packaging and labelling of dangerous substances in compliance with the E.E.C Directive 67/548 and 99/ 45.
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